1. Field of the Invention
This invention relates to a bulk unit of use informational medicinal dispensing system. More particularly, the invention is concerned with a pharmaceutical dispensing system comprising an envelope having attached to one side multiple, preprinted flaps containing government-required or other information relating to a given medication, space on the opposite side for the encoding of prescription information, and a bulk blister sheet perforated in a manner to allow for easy detachment of individually-packaged doses of medication in quantities called for by the prescription.
2. Description of the Prior Art
Over the past several years, a great deal of concern has been expressed by physicians, regulatory agencies and government officials about the problems of drug abuse in the consumptions of prescription medications. In attempting to address the problems, increasingly stringent regulations have been proposed regarding the need for complete information about the medication, its contraindications, side effects and potential dangers. Ideally, such information should be presented in lay terms and dispensed along with the medications to the patient. The possibility of the passage of such regulations requiring, in some cases, that pages of information be dispensed along with the medication has prompted a great deal of consideration of systems which would provide for the dissemination of detailed drug information while solving the more traditional problems of handling, packaging, storing and keeping records of medications associated with the pharmaceutical industry. Specifically, it is recognized that the ideal system would attain the following objectives:
provide for drug information in lay terms to be dispensed with the prescription, PA1 eliminate prescription vials, the space which they occupy and the cost associated with their procurement, PA1 eliminate the need for cotton and concomitantly eliminate moisture retention and contamination in the prescription vial, PA1 eliminate cross-contamination by avoiding the use of the same counting tray for a number of different types of medication, PA1 prevent product mix-up by avoiding the need to return product to a bulk container after counting, PA1 clear product identification and built-in child resistance for each dosage, PA1 provision for recording in the patient profile ledger, PA1 elimination of the need to handle several unit of use sizes, PA1 preservation of shelf life of medication to the expiration date by eliminating the need for repackaging. PA1 1. one or more flaps attached to one of its ends for the encoding of preprinted information; PA1 2. space on the opposite side for the encoding of label information; PA1 3. a removable, perforated strip at its open end, said strip having, on one side, space for encoding patient profile information and, on the other side, an adhesive; PA1 4. a foldable strip from which said removable, perforated strip is torn; said strip having, on one side, an adhesive; PA1 1. a base perforated in such a manner as to produce 50-100 individually-detachable squares; PA1 2. a paper foil laminate backing and; PA1 3. a plastic bubble on each square for the containment of each individual dosage of medication.
A number of pharmaceutical dispensing systems have appeared in the prior art which have sought to attain the aforedescribed objectives. For example, U.S. Pat. No. 3,958,690 to Gee, Sr. discloses a system for providing identification and medical information together with a dose of medication for emergency use by or for a patient. The system comprises a transparent envelope, a medical identification card and instructions for administration of the medication and a medication-containing package for insertion therein. The system described is primarily directed to convenience and ease of identifying the nature of the illness in an emergency and dispensing to the patient uniform doses of a given medication as limited by predetermined packet sizes geared to providing dosages in the unit of use most frequently described. Any variation of dosage which is not an exact multiple of the unit of use would occasion detachment of one or more individual doses from the predetermined unit of use size and adding said doses to the prescription. The leftover dosages remaining in the impaired unit size package would then be stored for counting and filling future prescriptions.
U.S. Pat. No. 3,305,077 to Grief et al. discloses a pharmaceutical dispensing system wherein a blister package containing individually-packaged doses of medication is provided for insertion into a transparent cellophane envelope. The focal concept of this disclosure is having the dispensing medium itself act as a dose indicating device to remind the user to take or confirm the administration of medicament at specified hours. The system also provides for administration data on an outer, protective sleeve of the package which is inserted into the transparent envelope. Additionally provided with the system is an attached writing instrument.
U.S. Pat. No. 3,958,750 to Prybeck discloses a package formed of three sheets of polyolefin plastic with an open envelope on one side for a hospital medicine card and a closure-equipped flap on the other side for a pouch holding medication. The system additionally provides for a flap to hold a hyperdermic syringe.
U.S. Pat. No. 2,877,893 to Volckening et al. discloses a package for the containment of small articles comprising a plurality of layers of sheet material sealed together with the commodity between them, said package being associated with a label, direction sheet, leaflet or the like bearing indicia or printed matter pertaining to the contents of the package.
In each of the prior art disclosures, it is clear that certain of the aforedescribed objectives have been attained. However, serious drawbacks to each of the prior art systems exist primarily with respect to lack of flexibility in predetermined unit dosage sizes and in lack of provision for complete information relating to the medication to be dispensed along with the medication. Now, in accordance with the present invention, a bulk unit of use informational dispensing system is disclosed which accomplishes the aforedescribed objectives and eliminates the problems associated with the prior art. The terminology "bulk unit of use" is a contradiction in terms in that "unit of use" refers to the packaging of medication in a manner which allows predetermined, prepackaged dosages to be dispensed, and the terminology "bulk" refers to large quantities of a given medication packaged in a manner which allows flexibility in filling dosages of any size. By the practice of the present invention, the flexibility associated with bulk packaging, the avoidance of contamination, easy storage, long shelf life and simplified accounting associated with unit of use packaging are combined with label and preprinted information to provide a system which optimally accomplishes the aforedescribed objectives.